Hot Watch List (comments).
HEB (updated to speculative buy 12.14.12)
So, we have 3 trade days before HEB panel vote for rintatolimod (trade name Ampligen) that is drug for the treatment of chronic fatigue syndrome (CFS). And ridiculously low pps ($0.69) for biotech that have NDA accepted by FDA even without additional phase III trials.
Do you remember something like this? <70 cents in front of Adcom?
Most of analysts including AF from Street said that panel will vote against approval. But why? If panelists reject this CFS drug patients will not see another opportunity in next 5-10 years. Well, may be this drug is not very effective but what is about cancer drugs that just give patients 3-4 months of life? One idiot even said that panel will vote negatively because the etymology of CFS is still under question... What is about Alzheimer's disease or HD or IPF?
For me the answer is clear here: FDA wants this drug approved. USA patients should get a cure against this chronic fatigue syndrome even if this drug is working as a placebo. Who care? Patients should get it, be assured that they are cured and go to real life.
That is my opinion only. So, I bought 45k HEB and will wait Adcom vote in next week.
12.18.12 by BiotechInvest
Ampligen documents released today are positive for approval. Drug is safe and effective enough to get positive vote. >1M patients in USA are waiting for any treatment and panelists know this. They voted positive for lupus drug, IPF and etc.
The FDA noted the lack of available treatments for chronic fatigue syndrome but said a product must "clearly demonstrate substantial" evidence of effectiveness and have a safety profile that can be evaluated.
The FDA asked Hemispherx to conduct an additional study of the product, but the agency eventually agreed to instead accept new analyses of existing data amid a broader agency effort to facilitate the development of drugs for chronic fatigue syndrome. Ampligen, an injectable drug, is believed to boost the body's immune system and fight viruses.
This is the answer: FDA wants this drug to be approved and now.
“Cognition” improved in patients in the AMP-502 and AMP-509 study, including improvement in their ability to remember things, less frequent episodes of one’s mind “going blank”, and other improvements. A greater number of patients significantly improved medically on Ampligen and fewer patients became worse, which may be the natural course of the chronic disease. Ampligen treatment therefore alters the expected downhill trajectory of untreated debilitating, life threatening CFS. Patients on Ampligen showed a reduction in hospitalizations including hospitalizations associated with suicide ideation when compared to the placebo group. Hospitalizations, emergency room admission and/ or inpatient admissions were reduced in patients with CFS receiving Ampligen compared to placebo. Prolonged Ampligen treatment showed no propensity to auto-immunity and indeed patients on Ampligen show a trend to decrease in preexisting auto-antibodies, a potential early step in forming autoimmune disease. The risks associated with Ampligen are minimal and well-documented. Ampligen treated patient show no increase in the incidence of cancer.
In summary, CFS is a serious, life threatening and unmet medical need. There are currently no FDA approved products specifically for the treatment of CFS. Ampligen has the potential to be a positive therapeutic option for patients with CFS who do not have an alternative to directly treat the condition. Given the overwhelming physical and cognitive health issues; the decrease in activities of daily living and overall lack of quality of life associated with CFS, Ampligen clearly represents a clinically meaningful advance for a significant unmet medical need, and the weight of evidence supports FDA goals to advance treatment for chronically ill patients with severe debilitating, life threatening, conditions such as severe CFS.
It can be stated that the burden of the symptoms associated with CFS is greater than any risks associated with Ampligen, since a CFS sufferer’s life may be at risk for years of debilitation often followed by premature death.
01.31.2013 by BiotechInvest
Sorry for your losses if you followed me with HEB investment. I still have it because there is some significant probability of FDA approval. FDA got panel vote that drug is safe, this is most important. It 's not enough data for efficacy prove but doctors that will prescribe this drug to CFS patients will get it in the future. They prescribe only palliative drugs now and can't say to patients that it's CFS drug approved by FDA. I'm sure that many patients will be cured with Ampligen because they will believe that this is CFS drug (placebo effect).
Disclosure: will keep HEB through PDUFA